aFAHL1_14 Preclinical and Clinical Trials of Medicines

Farmaceutická fakulta
podzim 2025

Předmět se v období podzim 2025 nevypisuje.

Rozsah
1/0/0. 14p. 2 kr. Ukončení: zk.
Vyučující
PharmDr. Bc. Kateřina Horská, Ph.D. (přednášející)
Garance
PharmDr. Bc. Kateřina Horská, Ph.D.
Ústav farmakologie a toxikologie – Ústavy – Farmaceutická fakulta
Omezení zápisu do předmětu
Předmět je určen pouze studentům mateřských oborů.
Mateřské obory/plány
Cíle předmětu
Research and development of new drugs is a multidisciplinary procedure in which many different disciplines like chemistry, biology, pharmacy, medicine as well as sociology, economy and law play their important role. Pharmacology is crucial both in preclinical and iclinical phases.

The target of the subject "Preclinical and Clinical Drug Research and Development" gives handy basic information on practical aspects of drug evaluation in the mentioned phases with the aim to enlarge knowledge of pharmacy students so they will be able to start their careers also in R&D departments.
Výstupy z učení
After completing the course the student will be able to - describe drug development and interpret legal aspects of this process - interpret the main principles of pharmacovigilance and pharmacoeconomics - Participate in preclinical and clinical drug trials
Osnova
Lectures Content
1.Biological activity testing, evidence of activity on the target cells, test on organs and whole organism, ethical aspects of preclinical studies - legal status, ethics commitee ,good laboratory practice.
2. Tolerability testing , toxicity tests - acute, subchronical and chronical toxicity, toxicity of reproduction. Data transfer possibility from animals to human- biological similarity. Pharmacokinetic and bioequivalence studies.
3. Clinical trials as a part of clinical research, phases of clinical trials, their organise and specific aspects, primary and secundary objectives, parametres for effects and tolerability evaluation. Metodological aspects of clinical trials, Good Clinical Practice - principes, harmonization, terminology, SOP, monitoring, zacházení s hodnocenými vzorky, důvěrnost údajů, zajišťování kvality, audity, inspection, data clarification. Essential dokuments - protocol, CRF, IS.
4. Principles of statistical analyses used in clinical research - basic terminology, randomization, study design, hypotheses, statistical tests, statistical analyses results interpretation.
5. Legal aspects , fundamental and related acts. Legaly requested activities of sponzor, investigator, trial subjekt. Contract research organisation . Contracts, fees, instance in clinical trials. Prerequisites for open clinical trial, regulatory and ethics committees requests . Ethical aspects , Czech nett of ethics committees and theire activities, Standard operating procedures, necessary documents.
6. Compliance and control mechanism. Sponsor, monitor and investigator responsibilities . Pharmacovigilance, adverse event and drug reaction.
7. Possible use of nonregistered drugs. Cooperation between pharmacy and organisers in clinical trials. Pharmacist activities in drug clinical research.
Literatura
    doporučená literatura
  • BROWN, M. J.; Pankaj SHARMA; Fraz A. MIR a P. N. BENNETT. Clinical pharmacology. Twelfth edition. Edinburgh: Elsevier, 2019, 1 online. ISBN 9780702073304. URL info
  • PIANTADOSI, Steven. Clinical trials : a methodologic perspective. Third edition. New York: Wiley, 2017, xxvii, 886. ISBN 9781118959206. info
Výukové metody
Monologue (reading, lecture, briefing) Discussion, interview, brainstorming
Metody hodnocení
Completion of the course – oral exam
Vyučovací jazyk
Angličtina
  • Permalink: https://is.muni.cz/predmet/pharm/podzim2025/aFAHL1_14